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The iHealth® COVID-19 Antigen Rapid Test is a lateral flow assay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2.This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older with symptoms of COVID-19 within the first 7 days of symptom onset. This test is also authorized for non-prescription home use with adult-collected nasal swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset.This test is also authorized for non-prescription home use with self- collected anterior nasal (nares) swab samples from individuals aged 15 years or older, or adult collected anterior nasal swab samples from individuals aged 2 years or older, with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over3 days with at least 24 hours (and no more than 48 hours) between tests. The test is a 15-minute self-test to detect whether or not an individual has the COVID-19. The test can be completed in the comfort of your own home without the need to ship your sample to a lab.Test can be done by inserting only 1/2 to 3/4 inch with a simple non-invasive nasal swab, easy to use and zero discomfort. Step-by-step instructional videos are available in our app for easy following. (Installation of app is optional.)The self-administered test is recommended for individuals aged 15 years and older. Adult-collection is required for testing chil- dren 2-14 years old.iHealth has completed testing on several heat inactivated vari- ant strains and the iHealth COVID-19 Antigen Rapid Test was able to detect the mutations.The iHealth Test app allows the administrator of a small group to monitor and track the group members’ test results when needed at school, work or event.
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